Archived Policies - Other


Photodynamic Therapy for Subfoveal Choroidal Neovascularization

Number:OTH903.015

Effective Date:12-01-2003

End Date:10-31-2007

Coverage:

Photodynamic therapy is considered medically necessary as a treatment of choroidal neovascularization associated with age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis. 

Photodynamic therapy is considered experimental or investigational for other ophthalmologic disorders.

Description:

PHOTODYNAMIC THERAPY

Photodynamic therapy is a treatment modality designed to selectively occlude ocular choroidal neovascular tissue. The therapy is a two-step process, consisting initially of an injection of the photosensitizer verteporfin, followed 15 minutes later by laser treatment to the targeted sites of neovascularization in the retina. The laser treatment selectively damages the vascular endothelium. Patients may be retreated if leakage from choroidal neovascularization persists.

There is currently one intravenous photodynamic therapy agent, verteporfin (VisudyneTM) that has received approval by the U.S. Food and Drug Administration (FDA) for treatment of choroidal neovascularization. While choroidal neovascularization may be associated with a wide variety of ophthalmologic conditions, the labeled indications include predominantly classic subfoveal choroidal neovascularization associated with age-related macular degeneration, pathologic myopia, and presumed ocular histoplasmosis.

Prior to the availability of photodynamic therapy, choroidal neovascularization was treated with photocoagulation using either argon, green, or infrared lasers. This conventional photocoagulation was limited to extrafoveal lesions due to the risk of retinal burns. However, recently, infrared lasers used at a low power setting have been investigational as a technique to photocoagulate subfoveal lesions.

AGE-RELATED MACULAR DEGENERATION

Age-related macular degeneration (AMD) is a painless, insidious process. In its earliest stages, it is characterized by minimal visual impairment and the presence of large drusen and other pigmentary abnormalities on ophthalmoscopic examination. As AMD progresses, two distinctively different forms of degeneration may be observed. The first, called the atrophic or areolar or dry form, evolves slowly. Atrophic AMD is the most common form of degeneration and is often a precursor of the second form, the more devastating exudative neovascular form, also referred to as disciform or wet degeneration. The wet form is distinguished from the atrophic form by serous or hemorrhagic detachment of the retinal pigment epithelium and the development of choroidal neovascularization (CNV), sometimes called neovascular membranes.  Risk of developing severe irreversible loss of vision is greatly increased by the presence of CNV.

The pattern of CNV, as revealed by fluorescein or indocyanine angiography, is further categorized as classic or occult. For example, classic CNV appears as an initial lacy pattern of hyperfluorescence followed by more irregular patterns as the dye leaks into the subretinal space.  Occult CNV lacks the characteristic angiographic pattern, either due to the opacity of coexisting subretinal hemorrhage or by a tendency for epithelial cells to proliferate and partially or completely surround the new vessels (especially in CNV associated with AMD). Interestingly, lesions consisting only of classic CNV carry a worse visual prognosis than those made up of only occult CNV, suggesting that the proliferative response that obscures new vessels may also favorably alter the clinical course of AMD.

PRESUMED OCULAR HISTOPLASMOSIS

Presumed ocular histoplasmosis may be the second most common cause of blindness in patients younger than 50 years of age in certain endemic areas (the Ohio and Mississippi River valleys in the U.S.). It is a condition characterized by a positive skin test for histoplasmosis, miliary opacities of the lungs, tiny choroidal scars, peripapillary disruption of the choriocapillaris, and exudation or hemorrhage from choroidal lesions in or near the macula. The condition is asymptomatic and benign unless the choroidal neovascular lesions, which may develop many years after chorioretinal scarring has taken place, affect the macula.

PATHOLOGIC MYOPIA

Pathologic myopia refers to an abnormal elongation of the eye associated with severe near-sightedness.  It generally occurs among people over 30 years of age and can result in a progressive, severe loss of vision, frequently related to the development of CNV.

The frequency and total number of treatments are not addressed in the U.S. Food and Drug Administration (FDA) labeled indication.  However, in the clinical pivotal trials presented to the FDA, patients were treated every 3 months if additional leakage was identified.

Rationale:

This policy is based in part on a 2000 TEC assessment that offered the following observations and conclusions:

Two multicenter, double-masked, randomized placebo-controlled trials including 402 patients reported that at one year of follow-up, fewer patients treated with photodynamic therapy experienced a clinically significant loss of visual acuity compared to those treated with placebo: 38.8% compared to 53.6% (p<.001). 

Subgroup analysis suggests that the treatment effect is predominantly experienced by those patients with age-related macular degeneration characterized by at least 50% classic choroidal neovascularization. 

There were inadequate data to permit scientific conclusions regarding other etiologies of choroidal neovascularization.

The TEC assessment did not specifically address the issue of frequency of treatment or treatment extending beyond one year.  Since the completion of the TEC assessment, the two-year results of the pivotal Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) randomized trial of patients with AMD were published.  Beneficial outcomes regarding visual acuity and contrast sensitivity noted after 12 months were sustained through 24 months. At the end of two years, 53% of the treatment group compared to 38% of the placebo group lost fewer than 15 letters. The average number of applications of verteporfin treatment in the second year (2.2) was lower than that required during the first year (3.4). A subgroup analysis was reported, comparing results between those patients with predominantly classic CNV (>50% of lesional area) compared to minimally classic CNV (<50%). For patients with minimally classic disease, no statistically significant differences in visual acuity were noted.  The Verteporfin in Photodynamic Trial (VIP) is another randomized study that primarily focused on efficacy of photodynamic therapy in patients with occult but no classic lesions that were presumed to have progressive disease due to visual or anatomic deterioration within the previous 3 months. Of the 339 patients enrolled in the trial, 76% had occult disease; the remainder had early classic CNV with good visual acuity. Similar to other randomized trials, the primary outcome was the proportion of eyes with fewer than 15 letters of visual acuity loss. While there was no significant difference between the treatment and placebo group at 12 months, by 24 months a significantly lower percentage of those with occult CNV had lost vision (55% vs. 68%, p=.032). These results contrast with those of the TAP trial, although the patient populations are slightly different. The TAP trial required all patients to have some percentage of classic CNV, while the VIP trial recruited patients with occult disease without any evidence of classic CNV. In addition, the VIP trial required patients with occult disease to have experienced recent deterioration in vision. Results for the subgroup of patients with classic CNV (but good visual acuity) were not reported separately.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

None

References:

BCBSATechnologyEvaluationCenter, Volume 15 #18 (December 2000) Photodynamic Therapy for Subfoveal Choroidal Neovascularization

BCBS Association Medical Policy Photodynamic Therapy for Subfoveal Choroidal Neovascularization Other, Vision 9.03.08 (Nov. 2001)1-5.

TAP Study Group: Photodynamic therapy of subfoveal choroidal neovascularization in age-related degeneration with verteporfin: two year results of 2 randomized clinical trials Arch Ophthalmol 2001; 119:198-207.

Verteporfin in Photodynamic Therapy (VIP) Study Group: Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: two-year results of a randomized clinical trial including lesions with occult with no classic choroidal neovascularization Am J Ophthalmol 2001; 131:541-60. 

Verteporfin in Photodynamic Therapy (VIP) Study Group: Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin Ophthalmology 2001; 108:841-52.

Photodynamic therapy with verteporfin for age-related macular degeneration American Academy of Ophthalmology Ophthalmology (2000 Dec) 107(12): 2314-7.

An additional search of literature was completed through the MEDLINE database for the period of January 2000 – January 2003. No additional information was found specific to this topic.

Policy History:

Archived Document(s):

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